FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319745212
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
231-007
Catalog number
231-007
Device description
"HUPP Trachea Retractor 6"", 3 sharp prongs 12mm wide and probe end 35mm long"
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCHHOOK, TRACHEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840319745212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319745212008403197452128403197452120840319745212

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12
00840319758892Hayden MedicalE7-0226E7-02262026-03-31
00840319758922Hayden MedicalE7-2234E7-22342026-03-31
00840319758939Hayden Medical210-179210-1792026-03-31
00840319758885Hayden MedicalE5-6271E5-62712026-03-27
00840319758854Hayden MedicalE5-6561E5-65612026-03-06
00840319758861Hayden Medical210-212210-2122026-03-05
00840319758878Hayden Medical210-213210-2132026-03-05
00840319758700Hayden Medical105-432-14105-432-142026-02-06
00840319758663Hayden MedicalE3-2623TE3-2623T2026-01-30
00840319737798Hayden Medical105-432105-4322023-03-17
00840319733134Hayden Medical105-432-10105-432-102022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031459MSI Precision Specialty InstrumentsMed Saver, Inc.KCH2025-08-01
04049047041801GimmiGimmi GmbHKCH2025-05-08
04049047014348GimmiGimmi GmbHKCH2025-04-24
04049047038078GimmiGimmi GmbHKCH2025-04-24
00887482058640Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KCH2024-08-07
00840183513825BR Surgical, LLCBR Surgical, LLCKCH2024-06-10
00190776390204MillenniumAvalign Technologies, Inc.KCH2024-05-31
00190776388997MillenniumAvalign Technologies, Inc.KCH2024-05-16
G043280300BEARBear-Ent, LLCKCH2024-04-25
00888515035676BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035690BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035706BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035720BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035737BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035744BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035751BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
G586G93151250Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
G586G93151260Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
00190776045661AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045678AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045777AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223892AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223939AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776321413MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321437MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321468MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321505MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321512MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
G2231336220Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKCH2023-08-23